Impact of Open Data Policies on Consent to Participate in Human Subjects Research: Discrepancies between Participant Action and Reported Concerns

Abstract

Research outlets are increasingly adopting open data policies as a requisite for publication, including studies with human subjects data. We investigated whether open data policies influence participants’ rate of consent by randomly assigning participants to view consent forms with and without discussion of open data policies. No participants declined to participate, regardless of condition, nor did rates of drop-out vs. completion vary between conditions. Furthermore, no significant change in potential consent rates was reported when participants were openly asked about the influence of open data policies on their likelihood of consent. However, follow-up analyses indicated possible poor attention to consent forms, consistent with previous research. Moreover, thematic analysis of participants’ considerations of open data policy indicated multiple considerations such as concerns regarding confidentiality, anonymity, data security, and study sensitivity. The impact of open data policies on participation raises complex issues at the intersection of ethics and scientific innovation. We conclude by encouraging researchers to consider participants as stakeholders in open data policy and by providing recommendations for open data policies in human subjects research.

Challenges and Best Practices Associated with Sharing Research Materials and Research Data for Communication Scholars

“…• When soliciting informed consent, participants must be made conspicuously aware of their data will be shared. Cummings et al (2015) found that participants were not less likely to consent to research in which their data were to be shared openly, although participants shared common concerns over confidentiality and data security (as well as common inattentiveness patterns with the consent procedure). During consent procedures, one consideration could be to discuss with participants what data will be shared, and perhaps even show them these data (e.g., a sample file prior to the study starting or even their actual data).…”

Open synthesis and the coronavirus pandemic in 2020

“…Need to maintain confidentiality [36,37] Research subjects are typically provided anonymity that may mean publication of raw data is not feasible or safe…”

A beginner’s guide to data stewardship and data sharing

“…Many issues regarding the release of confidential private data of individuals can be avoided by proposing an informed consent document in which subjects approve release of their de-identified data. Requesting such permission generally has not been found to reduce the percentage of participants who enroll in the research [51,52], but if such seems likely, an opt-out for the data release can be offered, which will affect only the size of the open data set distributed.…”